Renal insufficiency
Due to sparfloxacin is mainly excreted by the kidneys, correction of the dose of sparfloxacin is necessary in patients with renal insufficiency (see sections "With caution", "Method of administration and dose").
Crystalluria
To avoid the development of crystalluria, do not exceed the recommended daily dose. It is necessary to consume sufficient fluid and maintain an acid reaction of urine.
Prevention of photosensitization
During treatment with sparfloxacin and within 5 days after its termination, exposure to bright sunlight and ultraviolet rays should be avoided due to the risk of photosensitization. Sparfloxacin is contraindicated in patients whose living or professional conditions do not allow them to comply with the required precautions.
At the appearance of the first signs of phototoxicity, such as burning sensation of the skin, redness, swelling, blisters, rash, itching or dermatitis, treatment with sparfloxacin should be discontinued.
Secondary infection
As with the use of other antimicrobial agents with the use of sparfloxacin, especially prolonged, it is possible to develop a secondary infection associated with the growth of resistant to the preparation of microorganisms, to exclude and confirm which it is necessary to re-evaluate the patient's condition. If a secondary infection occurs during therapy, appropriate measures should be taken to treat it.
Peripheral Neuropathy
Patients receiving fluoroquinolones reported on the development of sensory and sensory-motor neuropathy, which may have a rapid onset. If patients develop neuropathy symptoms, treatment with sparfloxacin should be discontinued, thereby minimizing the possible risk of developing irreversible conditions (see "With caution").
Patients with glucose-6-phosphate dehydrogenase deficiency
Patients with diagnosed glucose-6-phosphate dehydrogenase deficiency may be predisposed to hemolytic reactions when treated with quinolones (see "Contraindications").
Pseudomembranous colitis, caused by Clostridium difficile
The appearance of diarrhea, especially in severe form, persistent and / or with an admixture of blood, during or after treatment with sparfloxacin may be a manifestation of pseudomembranous colitis. If suspected development of pseudomembranous colitis, treatment with sparfloxacin should be stopped immediately, and appropriate specific antibiotic therapy should be immediately prescribed (Vancomycin inside, teicoplanin inside or metronidazole inside). In the emergence of this clinical situation, preparations that suppress the intestinal peristalsis are contraindicated.
Patients who are predisposed to develop seizures
Like other quinolones, sparfloxacin should be used with caution in patients predisposed to develop seizures (patients with a history of CNS lesions, in patients who simultaneously receive drugs that reduce the threshold of seizure activity of the brain (theophylline, fenbufen [and other similar non-steroidal anti-inflammatory drugs]) (see "With caution"). With the development of seizures, treatment with sparfloxacin should be discontinued.
Tendonitis
Tendinitis, rarely caused by the use of quinolones, can sometimes lead to rupture of tendons, including Achilles tendon, especially in elderly patients and patients taking glucocorticosteroids simultaneously. This undesirable effect can develop within 48 hours after the start of treatment and be bilateral. In case of signs of tendonitis (inflammation of the tendon), it is recommended to immediately stop treatment. An appropriate treatment (for example, immobilization) of a damaged tendon may be required.
Interval lengthening QT
When using sparfloxacin, some patients may experience lengthening interval QT. Sparfloxacin should be used with caution in women and elderly patients. Because women have a longer interval than men QT, they may be more sensitive to drugs that extend the interval QT. Elderly patients are also more prone to the effects of drugs that affect the interval QT.
Interval lengthening QT is associated with an increased risk of ventricular arrhythmias, including polymorphic ventricular tachycardia.
Degree of lengthening interval QT may increase with increasing drug concentration, therefore, do not exceed the recommended dose.
When using sparfloxacin, the risk of developing ventricular arrhythmias in patients with predisposing arrhythmias may increase.
Concerning sparfloxacin contraindicated in:
- changes in the electrophysiological parameters of the heart, expressed in the lengthening of the interval QT: Congenital or acquired documented lengthening interval QT, electrolyte disturbances, especially uncorrected hypokalemia, clinically significant bradycardia; clinically significant heart failure with a reduced fraction of the left ventricular ejection; presence in the anamnesis of rhythm disturbances, accompanied by clinical symptoms:
- use with other drugs that extend the interval QT (see section "Interaction with other drugs").
Sparfloxacin should be used with caution:
- in patients with potentially proarrhythmic conditions,such as acute myocardial ischemia and cardiac arrest;
- in patients taking drugs, reducing the content of potassium.
Pseudo-paralytic myasthenia gravis (myasthenia gravis)
Fluoroquinolones are characterized by a neuromuscular blocking activity and may increase muscle weakness in patients with pseudo-paralytic myasthenia gravis. In the post-marketing period, serious adverse reactions were observed, including pulmonary insufficiency requiring artificial ventilation and fatal outcome, which were associated with the use of fluoroquinolones in patients with pseudo-paralytic myasthenia gravis. The use of sparfloxacin in a patient with an established diagnosis of pseudo-paralytic myasthenia is not recommended.
Severe skin reactions
When taking sparfloxacin, the development of severe bullous reactions, as Stevens-Johnson syndrome, toxic epidermal necrolysis. Patients should be informed that with the development of skin reactions and / or lesions of the mucous membranes, it is necessary to consult a doctor immediately before proceeding with sparfloxacin.
Hypersensitivity reactions and allergic reactions
With the use of fluoroquinolones, the development of hypersensitivity reactions and allergic reactions (anaphylactic shock and anaphylactoid reactions that can progress to a life-threatening state) has been reported. In these cases, the use of sparfloxacin should be discontinued and appropriate treatment initiated.
Psychotic reactions
Psychotic reactions, including suicidal thoughts / attempts, were noted in patients taking fluoroquinolones. In the case of the development of such reactions sparfloxacin should be canceled and appropriate treatment prescribed. Sparfloxacin should be administered with caution to patients with psychotic disorders (including history) (see section "With caution").
Dysfunction of the liver
Sparfloxacin should be used with caution in patients with impaired hepatic function, as liver damage may occur (see "With caution"). With the use of fluoroquinolones, cases of fulminant hepatitis have been reported, leading to the development of hepatic insufficiency (including fatal cases).Patients should be advised to stop treatment and consult a doctor if symptoms and signs of liver disease such as anorexia, jaundice, darkening of the urine, pruritus, abdominal pain are observed.
Disglycemia (hypo- and hyperglycemia)
With the use of fluoroquinolones, the development of both hypoglycemia and hyperglycemia has been reported. In patients with diabetes mellitus, receiving simultaneously oral hypoglycemic agents (for example, glibenclamide) or insulin, was reported on the development of hypoglycemic coma. It is recommended that blood glucose concentrations be carefully monitored in patients with diabetes mellitus.
Risk of development of resistance
The prevalence of acquired resistance may vary geographically and over time for individual species. Therefore, local information on resistance is required. It is necessary to carry out microbiological diagnostics with isolation of the pathogen and determination of its sensitivity, especially in severe infections or lack of response to treatment.
Infections caused by Escherichia coli
Resistance to fluoroquinolones Escherichia coli - the most common pathogen of urinary tract infections - varies indifferent geographic areas. Doctors are advised to take into account local resistance Escherichia coli to fluoroquinolones.
Infections caused by Neisseria gonorrhoeae
In connection with the increase in resistance Neisseria gonorrhoeae, sparfloxacin Do not use as an empirical treatment for suspected gonococcal urinary tract infection. Test for sensitivity of the pathogen to sparfloxacin should be performed in order to provide targeted therapy.
Methicillin-resistant Staphylococcus aureus
There is a high probability that methicillin-resistant Staphylococcus aureus will be resistant to fluoroquinolones. therefore sparfloxacin is not recommended for the treatment of established or suspected infections caused by methicillin-resistant Staphylococcus aureus, if laboratory tests did not confirm the sensitivity of this microorganism to sparfloxacin.
Infections of bones and joints
When infections of bones and joints should consider the need for combined use of sparfloxacin with other antibacterial drugs.
Impact on laboratory performance and diagnostic tests
Sparfloxacin can inhibit growth Mycobacterium tuberculosis, leading to false-negative results in the bacteriological diagnosis of tuberculosis.
When determining opiates and porphyrins in urine during treatment with sparfloxacin, a false positive result is possible. It may be necessary to confirm positive results using more specific methods.
Other
During the period of treatment is not recommended to use ethanol.